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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline Study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
2-chlorophenyl isocyanate
EC Number:
222-023-7
EC Name:
2-chlorophenyl isocyanate
Cas Number:
3320-83-0
Molecular formula:
C7H4ClNO
IUPAC Name:
1-chloro-2-isocyanatobenzene
Details on test material:
Purity: 99.4%, Molecular weight: 153.5 g/mol

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Hsd Poc: DH
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: dried corn oil
Concentration / amount:
Intradermal induction: 2.5% (=10 mg test substance/ animal)
Topical induction: 5% (=25 mg test substance/ animal)
Challenge: 3% (=15 mg test substance/ animal)
Challengeopen allclose all
Route:
other: During the challenge a hypoallergenic patch loaded with a 3% test substance formulation was placed on the left flank of the animals.
Vehicle:
other: dried corn oil
Concentration / amount:
Intradermal induction: 2.5% (=10 mg test substance/ animal)
Topical induction: 5% (=25 mg test substance/ animal)
Challenge: 3% (=15 mg test substance/ animal)
No. of animals per dose:
10 (substance group); 5 (control group)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
3%
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3%. No with. + reactions: 10.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
3%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
3%
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 3%. No with. + reactions: 10.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
3%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Any other information on results incl. tables

Number of animals exhibiting skin effects:

 

               Test substance group (10 animals)              Control group (5 animals)
         Test substance patch     Control patch        Test substance patch     Control patch
  Hours 48   72  total  48  72  48  72  total  48  72
   Challenge 3%  10  10  10  0  0  0  0  0  0  0

Applicant's summary and conclusion

Executive summary:

The Guinea Pig Maximization Test according OECD Guideline 406 was performed on male guinea pigs to determine whether the test substance exhibits skin-sensitizing properties.

The study was conducted with the following test substance concentrations:

Intradermal induction: 2.5%, Topical induction: 5% and Challenge: 3%.

For the induction and the challenge treatment the test substance was formulated in corn oil (dried) to yield a solution.

The challenge using a 3% test substance formulation led to skin effects in all animals in the treatment group and in none of the animals in the control group.

In summary, under the conditions of the maximization test and with respect to the evaluation criteria the test substance therefore thus exhibits a skin-sensitization potential.